BOSTON -- A pharmaceutical company which manufactures a painkiller that Gov. Deval Patrick banned from use in Massachusetts filed a lawsuit in U.S. District Court Monday, asking the court to grant an injunction to stop the governor’s executive order that prohibits Massachusetts doctors from prescribing or dispensing the drug.

In the lawsuit, Zogenix Inc., makers of Zohydro ER, argue the governor’s ban is in “direct conflict” with the authority of the Food and Drug Administration to determine on the public’s behalf if a drug is safe and effective. The FDA approved Zohydro ER in October 2013.

The company said the legal action comes after a formal written request to the governor for a meeting about the product “went unanswered.” The lawsuit was filed in U.S. District Court in Massachusetts.

A spokeswoman for the governor said the Department of Public Health was working on a statement responding to the lawsuit.

Patrick banned Zohydro ER almost two weeks ago after declaring a public health emergency around the heroin and opioid addiction epidemic in the state. During a press conference announcing emergency steps the Patrick administration would take to combat the drug problem, the governor said he would ban any hydrocodone-only formulation, commonly known as Zohydro. Patrick said it poses a “significant risk to individuals already addicted to opiates and to the public at large.”

“Zohydro is a dangerously addictive pharmaceutical painkiller approved by the FDA recently, over the objection of their scientific advisory council and is not available in an abuse-deterrent form,” Patrick said during the press conference on March 27. “Until it is available in such a form or better until the secretary of HHS at the federal level or the Congress has acted on the request to overturn the FDA, Zohydro will not be available in Massachusetts.”

The Patrick administration said the ban would last until state authorities determine measures are in place to safeguard against the potential for misuse, overdose or diversion.

Zogenix officials have said they have taken steps to prevent misuse of Zohydro, and dispute claims that it is more addictive or powerful than other commonly prescribed opioids.

"Governor Patrick's unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order," Roger Hawley, chief executive officer of Zogenix, said in a statement. "Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data. This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states."

Page 2 of 2 - Amy Larkin, a spokeswoman for Zogenix, said in an email there has been a “significant amount of misinformation in the media about Zohydro ER.”

“For patients in severe chronic pain who need hydrocodone, but are at risk for potentially fatal acetaminophen induced acute liver damage, Zohydro ER may be the only option for these patients to manage their pain,” Larkin wrote.

Larkin said Zohydro is not ten times more powerful than Vicodin, and it is not the most powerful opiate in its class. There are other marketed opioids that are more potent than hydrocodone, such as oxymorphone, methadone, hydromorphone and fentanyl, according to Larkin.

Last week, Deborah Allwes, director of prescription monitoring and drug control at the Department of Public Health, stated a physician in a hospital or extended care facility may not order hydrocone-only extended release for an admitted patient under their care, and added a pharmacy in Massachusetts will not be able to fill a prescription from a neighboring state for hydrocone-only extended release.

In declaring a public health emergency around the heroin-use and opiate epidemic, Patrick, along with Department of Public Health Commissioner Cheryl Bartlett, announced several steps they planned to take to address the problem, including authorizing all first responders to carry and administer Naloxone, commonly known as Narcan, which can reverse the effects of an overdose and prevent death.

At least 140 have died of heroin overdoses in Massachusetts during the past several months, Patrick said during the press conference.